BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø2.5 L110/85 2FLUTE F/QC

    MDR report key: 13714629 · Received March 9, 2022

    Report

    Report Number
    8030965-2022-01483
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 9, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819018631
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: GFA, HSZ, AND GFF. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H4 DEVICE HISTORY, PRODUCT CODE: 310.250, LOT NUMBER: 53P2744, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 20 MAY 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, BY PLACING A CORTEX SCREW INTO THE SHAFT OF THE BONE THROUGH THE PLATE; THE 2.5 DIAMETER DRILL BREAKS DURING HANDLING (WHEN THE BONE WAS BEING DRILLED, THE DRILL MOUNTED ON THE MOTOR WITH ITS RESPECTIVE DRILL GUIDE IN POSITION), LEAVING A METAL FRAGMENT IN THE PATIENT. THE SURGEON DECIDES NOT TO REMOVE THIS PIECE OF METAL. THE SURGERY WAS NOT DELAYED DUE TO THIS INCIDENT AND AT THE MOMENT THE DIRECT IMPACT ON THE PATIENT IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE DRILL BIT Ø2.5 L110/85 2FLUTE F/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633020 DRILL BIT Ø2.5 L110/85 2FLUTE F/QC INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SYNTHES GMBH 53P2744 07611819018631

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention